Kornimate/medical-research-clean huggingface dataset:
adjunctive pregnenolone in veterans with mild tbi

Conditions: Traumatic Brain Injury

Summary: mild traumatic brain injury (tbi) is common among veterans who have served in oef/oif (operation enduring freedom in afghanistan/operation iraqi freedom) and other theatres. delayed symptoms may occur following tbi, including cognitive symptoms (impaired attention, processing speed, executive functioning), as well as behavioral symptoms such as anxiety, depression, and irritability (fann et al. 2004; holsinger et al. 2002). neuroactive steroids have neuroprotective effects in rodent models of tbi (djebaili et al. 2005; djebaili et al. 2004; he et al. 2004; pettus et al. 2005; roof et al. 1997) and the neuroactive steroid pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats (akwa et al. 2001; flood et al. 1992; flood et al. 1995; vallee et al. 1997; vallee et al. 2003). in humans, reductions in pregnenolone (george et al. 1994) and its gabaergic metabolite allopregnanolone (uzunova et al. 1998) have been associated with depressive symptoms. pharmacological intervention with the neuroactive steroid pregnenolone could therefore result in a multi-targeted treatment approach, potentially improving cognitive deficits as well as anxiety and depression symptoms following tbi.

see brief summary

Eligibility criteria:
inclusion criteria: 1. 18-55 years of age, any ethnic group, either sex 2. history of mild tbi since september 2001. tbi occurring at age 18 or older. 3. we will adhere to the operational definition of mild tbi suggested by the world health organization task force (holm et al.2005), with the exception of the glasgow coma scale score criteria (not available for these participants). 4. ability to participate fully in the informed consent process. 5. no anticipated need to alter medications for the 10-week duration of the study. exclusion criteria: 1. for this pilot study, we will exclude patients who report a history of seizures. 2. serious unstable medical illness. history of cerebrovascular accident, prostate, uterine, or breast cancer. use of oral contraceptives or other hormonal supplementation such as estrogen. 3. current active suicidal and/or homicidal ideation, intent or plan. 4. concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary. 5. current dsm-iv (diagnostic and statistical manual, fourth edition) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than tbi. 6. female patients who are pregnant or breast-feeding. 7. known allergy to study medication.

Keywords: tbi pregnenolone cognition
a master protocol (amaz): a study of mirikizumab (ly3074828) in pediatric participants with ulcerative colitis or crohn's disease (shine-on)

Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic; Inflammatory Bowel Diseases; Crohn's Disease

Summary: the main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (uc) or crohn's disease (cd). the study will last about 172 weeks and may include up to 44 visits.


Eligibility criteria:
inclusion criteria: * participants from originating studies (i6t-mc-amba \[nct05784246\], i6t-mc-ambu \[nct04004611\], i6t-mc-amam \[nct03926130\]) , i6t-mc-amay \[nct05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab * participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. * female participants must agree to contraception requirements. exclusion criteria: * participants must not have developed a serious adverse event (sae) or adverse event (ae) in originating study or developed other condition before first visit of study amaz that continued treatment with mirikizumab would present an unreasonable risk for the participant. * participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in study amaz. * participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. * participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. * participants must not have adenomatous polyps that have not been removed. * participants must not be pregnant or breastfeeding.

Keywords: pediatric ulcerative colitis pediatric crohn's disease pediatric uc pediatric cd
study of aav5-hfix in severe or moderately severe haemophilia b

Conditions: Hemophilia B

Summary: this is an open-label, extension study enrolling patients who have successfully completed all assessments in study ct-amt-060-01 (years 1-5). assessment phase will begin at visit 36 (the first clinical visit in this extension study, approximately 5.5 years after the initial dosing visit study ct-amt-060-01) and go to visit 45 (10-years post-dosing in study ct-amt-060-01).


Eligibility criteria:
inclusion criteria: * subjects with congenital hemophilia b who completed study ctamt-060-01 * able to provide informed consent following receipt of verbal and written information about the trial. exclusion criteria: * enrolled subjects will have already been assessed based on the exclusion criteria for study ct-amt-060-01.
aistcm-outcome measurement of acute ischemic stroke with traditional chinese medicine

Conditions: Cerebral Infarction

Summary: the purpose of this study is to determine whether traditional chinese medicine (tcm) is able to improve the outcome of acute ischemic stroke and to observe its safety.

the purpose of this study is to determine whether traditional chinese medicine (tcm) is able to improve the outcome of acute ischemic stroke and safety.

Eligibility criteria:
inclusion criteria: * ischemic stroke diagnosis by ct/mri scan * yin pattern of traditional chinese medicine theory * 40-85 years old * total anterior circulation infarcts (taci), partial anterior territory cerebral infarction (paci), lacunar anterior circulation infarcts (laci) type under oxfordshire community stroke project (ocsp) standard * nihss \>=4; * glasgow coma scale (gcs) \>=7; * modified rankin scale less than 2 degrees before onset of this stroke * informed consent signed by patient or his/her family exclusion criteria: * hemorrhagic stroke; * coma, gcs\<=7; * cerebral hernia; * serious heart, liver, lung, kidney functional failure; * gastrointestinal (gi) bleeding; * thrombolysis drugs or surgery was administrated to the patient; * not cooperative with physician; * psychological disorder; * already taken part in other clinical drug trial within the past 3 months

Keywords: acute intracerebral infarction
endothelial dysfunction in post-infection fatigue syndromes

Conditions: Chronic Fatigue Syndrome; Long COVID

Summary: post-infection chronic fatigue syndromes, such as myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs) and post-covid-19 condition (long covid), are conditions primarily characterized by debilitating fatigue. this fatigue can range from mild, where patients are still able to participate in some social activities (e.g., school, work), to moderate and severe, where sufferers are predominantly homebound and bedridden. as a result, me/cfs and long covid not only negatively impact the quality of life of affected individuals and their caregivers but also represent a substantial and often silent burden on healthcare systems worldwide, including austria. this is primarily because most cases remain undiagnosed due to the lack of standardized clinical assessments and diagnostic markers. endothelial dysfunction, which is well known to affect blood flow, oxygen and nutrient delivery, and waste removal in the body, has been described as one of the key factors behind the symptoms experienced by me/cfs and long covid patients. however, the mechanisms that might explain the development of endothelial dysfunction remain largely unexplored. therefore, this project aims to evaluate key biological aspects related to the function of endothelial cells - a layer of cells lining blood vessels - using plasma samples from an austrian cohort of me/cfs and long covid patients. we expect that the findings from our study will provide new insights to better understand endothelial dysfunction in post-infection chronic fatigue syndromes, leading to improved patient stratification and tailored treatment alternatives.


Eligibility criteria:
inclusion criteria: the inclusion criteria for me/cfs patients not infected with sars-cov-2 (n=17; females: 70.59%; age (years): 40.10 ± 10.80) and long-covid patients (n=30; females: 73.4%; age (years): 37.70 ± 9.96) include profound fatigue and at least one of the following symptoms: pem, autonomic dysfunction, and/or orthostatic intolerance. all participants were included only if they were at least 12 weeks past an acute ebv infection and/or 10 weeks past an acute sars-cov-2 infection, respectively. sars-cov-2 specific iga (a) and igg (b) antibody titers were measured using commercial test kits (anti-sars-cov-2-elisa (iga) and anti-sars-cov-2-quantivac-elisa (igg); euroimmun, germany) in plasma samples. exclusion criteria: participants' exclusion criteria included evidence of acute malignant diseases, diabetes mellitus, acute sepsis, chronic inflammatory gastrointestinal diseases, and frequent intake of analgesics, antacids, or antibiotics. furthermore, no previously hospitalized sars-cov-2 patients were included, eliminating false-positive fatigue due to intensive care treatment, such as artificial respiration.

Keywords: me/cfs long covid endothelial dysfunction
internet-based system for cancer patients to self-report toxicity

Conditions: Cervical Cancer; Lung Cancer; Prostate Cancer; Vaginal Cancer; Ovarian Cancer; Breast Cancer; Bladder Cancer

Summary: cancer patients may develop side effects during treatment, such as nausea, pain, fatigue, diarrhea, constipation, or shortness of breath. these symptoms may be due to the cancer itself, or due to treatments like chemotherapy drugs or radiation therapy. doctors and nurses often ask patients about their symptoms, because an important part of cancer treatment is to make patients feel as well as possible. if patients do not feel well, the investigators may need to change the way the investigators are treating you or prescribe therapies that will decrease your symptoms. the best way to find out how you are feeling is to ask you directly. however, during your time between appointments the investigators may not be able to ask you how you are feeling on a regular basis. in addition, even at an appointment, there may be symptoms that the investigators do not have a chance to discuss. the investigators are interested in developing new ways to ask patients about how they are feeling, using the internet. a special new website called star ("symptom tracking and reporting for patients") has been developed to help patients record this information, so that their doctors and nurses can review it during clinic appointments. this study is designed to help us see if star is a helpful way for us to keep track of information about patients' symptoms and quality of life.

this pilot study will assess patient use of star (symptom tracking and reporting for patients), an online system designed for cancer patients to self-record toxicity-related symptoms based on nci common terminology criteria for adverse events v3.0, performance status by ecog criteria, global quality of life by the euroqol 5-d assessment tool, emergency room visits, and survival. secondary outcomes will include patient assessment of the usefulness of star, clinician perceptions of the potential value of star in routine clinical practice, and an evaluation of whether star improves the patient experience of care as assessed by satisfaction measures.

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of gynecologic (ovarian; cervical; uterine; primary peritoneal), lung (non-small cell; small cell), gastrointestinal (colorectal, rectal, gastric, esophageal, gi neuroendocrine, small intestine malignancy, pancreatic, hepatocellular), breast, bladder cancer or prostate malignancy * receiving primary medical oncology care at mskcc medical oncology outpatient clinics * receiving cytotoxic chemotherapy not on a clinical trial (or a new hormonal therapy in the case of prostate cancer patients only), with treatment expected to continue for at least four weeks from the time of enrollment * signed informed consent and research authorization exclusion criteria: * ecog performance status greater than 2 * unable to read and comprehend english language text

Keywords: toxicity related symptoms 04-020
safety evaluation of edoxaban in elderly patients with frailty criteria

Conditions: Auricular Fibrillation

Summary: the aim of the present study is to prospectively evaluate the safety of edoxaban.

the aim of the present study is to prospectively evaluate the safety of edoxaban in daily clinical practice in spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (\<6 months prior to inclusion). the study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with edoxaban in real life and in a large subgroup, although underrepresented in the studies.

Eligibility criteria:
inclusion criteria: * patients 75 years of age or older with a diagnosis of nvaf. * patients in whom treatment had been started in the 6 months prior to enrollment in the study with edoxaban for prevention of stroke and systemic embolism after diagnosis of nvaf and according to the drug's technical data sheet. * frailty criteria according to the frail scale (score of 3 to 5 points). * written informed consent to participate in the study prior to any intervention. exclusion criteria: * creatinine clearance according to the ckd-epi formula less than 15 ml/min/m2 * moderate or severe hepatic insufficiency (defined as grade b or c of the child-pugh classification. * contraindication to receive edoxaban according to the technical data sheet. * participation in any clinical drug trial in the 2 months prior to the initial visit. * absence of recorded patient or treatment information. * surgical or percutaneous occlusion of the left atrial appendage or intention to perform such intervention at the time of inclusion. * any circumstance that, in the opinion of the investigator, affects patient follow-up (including life expectancy of less than two years or inability to perform follow-up). * persons who are legally incapacitated or unable to understand informed consent.
randomized comparison of laparoscopic sleeve gastrectomy and gastric bypass for morbid obesity

Conditions: Morbid Obesity; Metabolic Syndrome X; Diabetes Mellitus; Dyslipidemia; Hypertension

Summary: bariatric surgery is the most effective treatment for morbid obesity. roux-en-y gastric bypass (rygb) is a bariatric procedure with known safety and effectiveness. laparoscopic sleeve gastrectomy (lsg) is a newer procedure gaining popularity. the aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.

authors of the study believe that a more detailed head-to-head comparison of rygb and lsg is necessary. the former method is the established "gold standard" procedure with good outcomes reported in many studies. however it is much more complex and the learning curve is longer. the latter method was introduced as an initial procedure in superobese patients because of its relative simplicity. it produced good outcomes in this population of superobese patients and surgeons in some centers started to use it as a primary bariatric procedure. rygb is a restrictive and partially malabsorptive procedure and it is believed to have additional benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia. purely restrictive procedures such as lsg are theoretically less beneficial in this group of patients. in the present study authors will look at weight loss as well as improvement in comorbidities and several biochemical parameters and indices to assess also metabolic action of these two procedures.

Eligibility criteria:
inclusion criteria: * bmi≥40 kg/m2 * bmi≥35 kg/m2 with at least one comorbidity associated with obesity exclusion criteria: * bmi \> 60 kg/m2 * poorly controlled significant medical or psychiatric disorders * active alcohol or substance abuse * active duodenal/gastric ulcer disease * difficult to treat gastro-esophageal reflux disease with a large hiatal hernia * previous major gastrointestinal surgery * diagnosed or suspected malignancy

Keywords: bariatric surgery gastric bypass sleeve gastrectomy weight loss lipoproteins insulin resistance incretins quality of life
effects of mental practice in gait of individuals with parkinson disease: randomized clinical trial

Conditions: Parkinson Disease

Summary: the purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic parkinson's disease. it is believed that familiarity with the normal gait pattern, associated with mental practice and physical practice can trigger significant changes in spatiotemporal and angular parameters that are not observed in the group not submitted to mental practice.


Eligibility criteria:
inclusion criteria: * the subjects should be in use of antiparkinsonian medication, * be between stages 2 and 3 of the hoehn and yahr modified scale); * walk without any brace or aid device, independently (scores between 3 and 5 of the functional ambulatory category - fac) for at least 10 meters * were not undergoing stereotactic surgery. exclusion criteria: * we excluded those who were unable or declined to complete the training protocol.

Keywords: primary parkinsonism. rehabilitation. biomechanics. neurological gait disorders.
effects of different inhaled oxygen concentrations on lung function in older patients after laparoscopic gastrointestinal surgery under general anesthesia

Conditions: Oxygenation Index

Summary: this was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low fio2 (40%) and high fio2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery.

this was a multicenter, prospective, parallel-grouping, randomized controlled clinical study comparing low fio2 (40%) and high fio2 (80%) levels in older patients undergoing laparoscopic gastrointestinal surgery. the investigators planned to enroll 1098 subjects aged \> 65 years for laparoscopic gastrointestinal surgery at 19 clinical trial centers in china, randomized in a 1:1 ratio, to use two inhaled oxygen concentrations during surgery. all patients will be performed via the lung-protective ventilation strategy. the respiratory parameters are vt: 6-8ml/kg, peep: 6-8 cmh2o, rr: 1:2, and respiratory rate will be adjusted by maintaining a partial pressure of carbon dioxide at 35-45 mmhg. manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation. the main outcome measure was the oxygenation index on the postoperative 48h. the secondary outcome measures were the 7-day postoperative pulmonary complications and 30-day mortality rates et al.

Eligibility criteria:
inclusion criteria: * age not less than 65 years * american society of anesthesiologists grades i-iii * no history of drug allergies or abnormal anesthesia. * the duration of mechanical ventilation was expected to be more than 2 hours. * laparoscopic gastrointestinal surgery * the preoperative oxygen saturation was not less than 94%. * the patients will be planned to extubate in the operating room. exclusion criteria: * history of acute lung injury or acute respiratory distress syndrome (ards) within 3 months. * cardiac function class iv (new york heart association classification) * chronic renal failure (renal cell filtration rate \<30 ml min-11.73/m2), severe liver disease * patients with blurred consciousness and cognitive dysfunction * severe coagulation dysfunction. * without preoperative oxygen inhalation, blood oxygen level \<94%, and severe pulmonary dysfunction * patients with endotracheal tubes were admitted to the intensive care unit (icu) after surgery. * body mass index (bmi) \>30kg/m2 * inability to complete the study
a safety and efficacy study evaluating et-01 in subjects with transfusion dependent β-thalassaemia

Conditions: Transfusion Dependent Beta-Thalassaemia

Summary: this is a single-arm, open label, multi-center, single-dose phase 1 study in subjects with transfusion dependent β-thalassaemia. the study will evaluate the safety and efficacy of autologous crispr-cas9 modified cd34+ human hematopoietic stem and progenitor cells (hhspcs) using et-01.


Eligibility criteria:
key inclusion criteria: * subjects and/or legal representative fully understand and voluntarily sign informed consent forms. * diagnosis of transfusion dependent β-thalassemia (β-tdt) as defined by protocol. * be not appropriate to receive conventional allogeneic hematopoietic stem cell transplantation. * lansky/karnofsky score ≥ 70%. * eligible for hematopoietic stem cell transplantation and conditioning with busulfan as per investigator's judgement. other protocol defined inclusion criteria may apply. key exclusion criteria: * subjects with associated α-thalassemia. * subjects with any clinically significant acute or uncontrolled infections. * history of uncontrolled epilepsy or other mental disorders. * previous treatment with allogeneic bone marrow transplantation or gene therapy. other protocol defined exclusion criteria may apply.

Keywords: beta-thalassaemia crispr-cas9 human hematopoietic stem and progenitor cells
salvage therapy with high dose oral clarithromycin in relapsed or refractory extranodal marginal zone lymphoma

Conditions: Lymphoma

Summary: this is a prospective, phase ii study on the activity and tolerability of high dose (2 g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone lymphoma.

a 6-month regimen of oral clarithromycin has been associated with a 35% orr in patients with relapsed/refractory marginal zone b-cell lymphoma. responses were more common among patients with conjunctival lymphoma. this could be explained at least in part by the elimination of clarithromycin by tears, suggesting that a higher tumor bioavailability of this antibiotic could result in a higher activity. thus, a higher dose of clarithromycin could be associated with a higher tumor bioavailability in tissues other than the conjunctiva.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of extranodal extra-gastric marginal zone cell b lymphoma or gastric helicobacter pylori positive lymphoma refractory to conventional antibiotic therapy, or h. pylori negative * at least one measurable lesion * relapsed or refractory lymphoma after systemic (chemotherapy, immunotherapy, antibiotic) or local (surgery or radiation) therapy * ecog ps \</= 3 * no prior antibiotic therapy within 3 months before enrollment exclusion criteria: * hiv 1-2 infection * concomitant conventional or experimental antitumor therapy (chemotherapy, radiotherapy, immunotherapy, corticosteroids) * severe inadequate liver (ast \</=3 uln, alt \</= 3 uln, bilirubin \</=3 uln) or renal (creatinine \</= 1.5 uln) function * allergy to macrolides * concomitant malignant neoplasms within prior 5 years (with the exclusion of basal cell carcinoma, in situ spinocellular carcinoma of skin and cervix)

Keywords: malt refractory relapsed extranodal relapsed or refractory extranodal marginal zone lymphoma